K243675
- 510(k) number
- K243675
- Device name
- InkSpace Imaging Small Body Array
- Applicant
- Inkspace Imaging, Inc. CA · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2024-12-20
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243675.pdf
Official FDA record: K243675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.